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RECRUITING
NCT05545007
NA

Preoperative vs Postoperative Hypofractionated Radiosurgery for Patients With Large Brain Metastases

Sponsor: Istituto Clinico Humanitas

View on ClinicalTrials.gov

Summary

This is a phase III randomized trial with the aim to compare preoperative HSRS to postoperative HSRS in patients with large at least one BMs from solid tumors suitable for surgical resection.

Official title: Phase III Randomized Trial Comparing Preoperative Hypofractionated Radiosurgery (HSRS) to Postoperative Hypofractionated Radiosurgery (HSRS) for Patients With Large Brain Metastases (= 2.1cm) Suitable for Surgical Resection

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

146

Start Date

2023-01-31

Completion Date

2027-01

Last Updated

2025-04-24

Healthy Volunteers

No

Interventions

RADIATION

Hypofractionated Radiosurgery (HSRS)

HSRS converges multiple radiation beams to deliver a single, large dose of radiation to a discrete tumor target with high precision, thereby minimizing radiation dose to the surrounding normal tissue.

PROCEDURE

Brain metastases surgical resection

Complete surgical resection of brain lesions with adeguate margins.

Locations (9)

ASST Spedali Civili di Brescia

Brescia, Brescia, Italy

AOUC Azienda Ospedaliero-Universitaria Careggi

Florence, Florence, Italy

IRCCS Istituto Clinico Humanitas

Rozzano, Milano, Italy

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Milan, Italy

Ospedale del Mare

Naples, naples, Italy

Policlinico Umberto I

Rome, Rome, Italy

Fondazione Policlinico Universitario Agostino Gemelli

Rome, Rome, Italy

AOU Sant'Andrea

Rome, Rome, Italy

Azienda Ospedaliera Santa Maria di Terni

Terni, Terni, Italy